Senior Scientist External Manufacturing API and Drug Product Support

The Position Seeking an exceptional individual for a technical position within the Analytical Sciences – Science and Technology organization.  The successful candidate will be joining a group of innovative scientists with broad deliverables spanning activities across Active Pharmaceutical Ingredient (API) and Drug Product (DP) to drive efficiency gains in support of global supply operations. The incumbent will be expected to interact closely with the external Contract Manufacturing Organization sites across the manufacturing network in identifying, developing, implementing, and troubleshooting laboratory test methods, technologies and workflows as well as material for ensuring compliant, robust, and responsive supply. The individual will understand the technical, regulatory, and business needs for API and DP development and commercial supply, providing essential analytical support to ensure success.   A strong technical background with a superior problem-solving skill set, exceptional leadership abilities, strong knowledge of Current Good Manufacturing Practices and Data Integrity are considered essential, as these will be key attributes necessary to facilitate the ability to influence change in efforts to realize sustained, compliant supply of products to our patients.

Author analytical procedures, methods development and validation protocols and reports, technical reports, experimental designs, regulatory submission documents, etc. Perform investigations with strong technical troubleshooting skills and assist in developing/implementing Corrective Action and Preventative Actions. Provide documentation/technical input during inspections and audits (Regulatory and Internal) and have a working knowledge of data integrity and recent industry trends. The individual will also be responsible for technical training of staff, as needed, on analytical techniques and problem solving. In addition, the incumbent will keep up with regulation changes to help support plans to implement new strategies. Required Education, Experience & Skills BS or MS degree with at least 5 years of experience. PhD degree with at least 1 year of experience. Hands-on analytical chemistry lab experience. Possess practical knowledge in developing and applying analytical techniques like liquid and gas chromatography, and various spectroscopic methods to support drug substance and product development, registration, and unknown peak identification investigations. Experience collaborating with external service providers, proficiency in regulatory filing requirements, and ability to work effectively within cross-functional and interdisciplinary teams, demonstrating strong verbal and written communication skills. Demonstrate excellent interpersonal skills, adaptability, and cultural sensitivity. Skilled in tailoring communication, coaching, and collaboration to suit colleagues with diverse experience and expertise. Self-motivated to take ownership and accountability of issues and drive them to completion. Ability to speak up and raise issues, identify and communicate risks, and help to drive to resolution. Ability to quickly adapt to changes and develop appropriate plans for managing risks. Knowledge of drug product and/or API development and commercialization and understand the needs related to commercial quality control testing.   Preferred Experience & Skills: LCMS, GCMS, NMR Use of statistical software for data analysis (such as Excel, Minitab) Basic proficiency with using internal approved AI tools Who We Are: Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and